FDA.reportPublic FDA data

Amoxicillin

Product NDC
50090-1810
11-digit product format
500901810
Labeler code
50090
Product ID
50090-1810_06fe45e9-6194-46f5-9d58-c36b83ff4ea6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amoxicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065271
Marketing category
ANDA
Marketing start
2005-11-09
Substance
AMOXICILLIN
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amoxicillin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMOXICILLIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii804826J2HU
Rxcui308191

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1810-0Amoxicillin30 in 1 BOTTLECAPSULE3012
50090-1810-1Amoxicillin40 in 1 BOTTLECAPSULE4012
50090-1810-2Amoxicillin21 in 1 BOTTLECAPSULE2112
50090-1810-5Amoxicillin15 in 1 BOTTLECAPSULE1512
50090-1810-7Amoxicillin10 in 1 BOTTLECAPSULE1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1810-0EA - Each50090-1810161708be-d49d-4942-af65-c654a37272c512023-06-06
50090-1810-1EA - Each50090-1810ddc2e655-df9f-4ec2-9afd-06a320f655bb12023-06-06
50090-1810-2EA - Each50090-1810079f4350-d904-4853-8af1-8af6c4329a2812023-06-06
50090-1810-5EA - Each50090-1810b69fb732-cff1-4a97-bbbf-30f647e7456d12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1810AMOXICILLIN CAPSULE [A-S MEDICATION SOLUTIONS]12Current NDC, 5 package rows20240417_4d0f063a-d896-4757-8f22-9614e2ad71d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308191amoxicillin 500 MG Oral CapsulePSN4d0f063a-d896-4757-8f22-9614e2ad71d412
308191amoxicillin 500 MG Oral CapsuleSCD4d0f063a-d896-4757-8f22-9614e2ad71d412
308191amoxicillin (as amoxicillin trihydrate) 500 MG Oral CapsuleSY4d0f063a-d896-4757-8f22-9614e2ad71d412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-1810-05009018100030 CAPSULE in 1 BOTTLE (50090-1810-0) 30 capsule2015-05-07NoNoCurrent
50090-1810-15009018100140 CAPSULE in 1 BOTTLE (50090-1810-1) 40 capsule2015-05-07NoNoCurrent
50090-1810-25009018100221 CAPSULE in 1 BOTTLE (50090-1810-2) 21 capsule2015-05-07NoNoCurrent
50090-1810-55009018100515 CAPSULE in 1 BOTTLE (50090-1810-5) 15 capsule2015-05-07NoNoCurrent
50090-1810-75009018100710 CAPSULE in 1 BOTTLE (50090-1810-7) 10 capsule2023-05-09NoNoCurrent